Status:
COMPLETED
A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
65+ years
Brief Summary
The purpose of this study is to learn about how long novel hormonal therapies are taken by men to treat mCSPC. Novel hormonal therapies in this study include study medicines abiraterone, apalutamide, ...
Eligibility Criteria
Inclusion
- Male with ≥ 1 diagnosis claim for prostate cancer
- Have documented secondary metastasis code on or after the initial prostate cancer diagnosis
- Have initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 30 days prior to the metastasis date or on or after the metastasis date. The initiation date of the earliest novel hormonal therapy will be defined as the index date.
- Have a claim for androgen deprivation therapy (ADT) within 90 days prior to or within 30 days after the index date
- ≥65 years old 12 months prior to the index date
- Continuous enrollment in Medicare Parts A, B, and D for ≥12 months prior to the index date and ≥6 months following the index date (unless death)
Exclusion
- Claims indicating ≥8 weeks of continuous ADT use between 90 and 365 days prior to the index date, which may indicate castration-resistance
- Received chemotherapy, novel hormonal therapy, radium-223, PARP inhibitor, immunotherapy, or surgical castration prior to the index date
- Had a prior history of other cancers
Key Trial Info
Start Date :
October 4 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 18 2024
Estimated Enrollment :
3017 Patients enrolled
Trial Details
Trial ID
NCT06072196
Start Date
October 4 2023
End Date
December 18 2024
Last Update
December 31 2025
Active Locations (1)
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1
Pfizer, Inc
New York, New York, United States, 10001